A New Scoring System Improves Diagnostic Accuracy of Intestinal Dysganglionosis --a Prospective Study

NCT02216994 | Unknown DMC

• 2 other identifiers: TJCD-D-13-00074tj2014701
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The investigators previously reported a simple diagnostic scoring system to differentiate Hirschsprung disease (HD) from Hirschsprung disease allied disorders (HAD) in the patients with suspected intestinal dysganglionosis. In the retrospective study, the investigators concluded that the patients with a predicting score of more than 5 are more likely to be diagnosed with HD, whereas a score less than 5 is mostly indicative of HAD.
2. 2.Since it is essential to confirm the accuracy and efficacy of the scoring system in a prospective manner before it is used as a standard procedure, this prospective study is designed and performed.

Conditions

Hirschsprung Disease

Keywords

Intestinal dysganglinosis; Hirschsprung disease; Hirschsprung disease allied disorders; diagnostic scoring system; Prospective study

Outcome Measures

Primary Outcomes (1)

• the predicting score calculation

  The recruited patients is undergoing preoperative work-up including barium enema (BE), anorectal manometry (ARM) and histochemical acetylcholinesterase (AChE) staining of rectal mucosa. Known risk factors for IDs are recorded. The predicting score is calculated by summing the scores of the risk factors and 3 preoperative tests. The patients with a predicting score of more than 5 are diagnosed with HD, and are performed surgery to remove the aganglionic bowel. The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.

  6-12 months

Secondary Outcomes (1)

• pathological diagnosis

  12-18 months

Study Arms (1)

surgery treatment

OTHER

The patients with a predicting score of more than 5 are diagnosed with HD, and are performed surgery to remove the aganglionic bowel. The patients with a score less than 5 are mostly indicative of HAD, and receive conservative treatments that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments. one stage pull through procedure to remove the dysganglionic bowel segments.

Drug: high dose lactulose; Behavioral: conservative treatment; Drug: paraffin oil

Interventions

high dose lactulose DRUG

The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.

Also known as: Duphalac®

surgery treatment

conservative treatment BEHAVIORAL

The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.

Also known as: colonic irrigation

surgery treatment

paraffin oil DRUG

The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.

Also known as: Shilayou®

surgery treatment

Eligibility Criteria

• Age: 1 Day - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Hard or firm stools for 2 or less per week
• Age are from newborn to 3 years old

You may not qualify if:

• Children\>3 years of age
• Patients presented severe inflammation or malnutrition, unconsciousness or perforation of intestine

Sponsors & Collaborators

• Tongji Hospital: lead
• Jiangxi Province Children's Hospital: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Hirschsprung Disease

Interventions

Lactulose; Conservative Treatment; Mineral Oil

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Therapeutics; Petrolatum; Hydrocarbons; Organic Chemicals

Study Officials

• Jiexiong Feng, MD, PhD

  Tongji Medical College,Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongyi Zhang, MD

CONTACT

27-83665209; zhanghongyidoc@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of pediatric surgery department

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 15, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

CN (1)